Heart failure insufficient pump function of the heart
Conditions
Interventions
50% of the patients will be randomized to omecamtiv mecarbil, 50% to placebo
(1:1 ratio).
Omecamtiv mecarbil (OM) or placebo will be administered orally twice a day
(BID) in the morning and evening
Sponsors
Amgen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Subject has provided informed consent - Male or female, * 18 to * 85 years of age - History of chronic HF - LVEF * 35% - NYHA class II to IV - Managed with HF SoC therapies consistent with regional clinical practice guidelines - Current hospitalization with primary reason of HF or prior HF hospitalization, or urgent HF admission to emergency department (ED) within 1 year prior to screening - BNP level * 125 pg/mL or an NT-proBNP level * 400 pg/mL at most recent screening assessment (for subjects with atrial fibrillation, the cut off levels are: BNP * 375 pg/mL or NT proBNP * 1200 pg/mL)
Exclusion criteria
Exclusion criteria: - Inability to swallow study medication tablet - Receiving mechanical hemodynamic support or mechanical ventilation * 7 days prior to randomization - Receiving IV inotropes or IV vasopressors * 3 days prior to randomization - Receiving IV diuretics or IV vasodilators, or supplemental oxygen therapy * 12 hours prior to randomization - Acute coronary syndrome, stroke, or transient ischemic attack, major cardiac surgery, percutaneous coronary intervention, or valvuloplasty within the 3 months prior to randomization - Severe uncorrected valvular heart disease, or hypertrophic obstructive cardiomyopathy, active myocarditis, constrictive pericarditis, or clinically significant congenital heart disease - Routinely scheduled outpatient intravenous infusions for HF (eg, inotropes, vasodilators, diuretics) or routinely scheduled ultrafiltration - Systolic blood pressure > 140 mmHg or 90 mmHg, or heart rate > 110 beats per minute, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary Endpoint: - composite of time to CV death or first HF event, whichever occurs first An HF event is defined as the presentation of the subject for an urgent, unscheduled clinic/office/ED visit, or hospital admission, with a primary diagnosis of HF, where the patient exhibits new or worsening symptoms of HF on presentation, has objective evidence of new or worsening HF, and receives initiation or intensification of treatment specifically for HF (Hicks et al, 2015). Changes to oral diuretic therapy do not qualify as initiation or intensification of treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary Endpoints: * time to CV death * change in Kansas City Cardiomyopathy Questionnaire Total Symptoms Score (KCCQ TSS) from baseline to Week 24 * time to first HF hospitalization * time to all-cause death | — |
Countries
Netherlands
Outcome results
None listed